510(k) K945421
K945421 is an FDA 510(k) premarket notification submitted by Stephen Chakoff, Inc. for the device "CHAKOFF ENDOSCOPY". The FDA issued a decision of Substantially Equivalent on December 23, 1994. The device falls under product code FDG (Retractor, Fiberoptic), a Class I device regulated under 21 CFR 876.4530. Stephen Chakoff, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 23, 1994
- Date Received
- November 4, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Retractor, Fiberoptic
- Device Class
- Class I
- Regulation Number
- 876.4530
- Review Panel
- GU
- Submission Type